FDAFDA · Food and drugs·Recall number D-014-2014
Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, Distributed by G.D. Searle, Division of Pfizer Inc, NY, NY 10017, NDC 0025-1031-31
Published November 27, 2013 · Recall initiated: September 4, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ALDACTONE
- Manufacturer
- Pfizer Us Pharmaceutical Group
- Distributor
- US Nationwide
- UPC
- 0300251001314
- Lot
- Lot #: V121573, Exp 05/17
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States